EU MDR / IVDR

Section-by-section CER template for EU MDR compliance — covering clinical evaluation plan, device description, literature search protocol, data appraisal tables, equivalence justification, benefit-risk analysis, PMCF linkage, evidence traceability matrix, and Notified Body-ready formatting. Free alternative to gated competitor templates.

Practical guide for building a coordinated vulnerability disclosure (CVD) program for medical devices — covering PSIRT setup, vulnerability intake and triage, CVSS scoring, SBOM linkage, field safety notices, FDA Section 524B requirements, EU expectations, and customer communication templates.

Downloadable GSPR checklist template for EU MDR Annex I compliance — covering all 23 requirements across three chapters, with columns for applicability assessment, evidence files, harmonised standards mapping, gap analysis, owner assignment, and remediation tracking. Practical alternative to gated competitor templates.

With EUDAMED becoming mandatory on May 28, 2026, manufacturers are discovering that registration is far more complex than a simple data upload. Here are the 10 most common mistakes — and exactly how to avoid each one.

Practical regulatory guide for home-use and self-test in vitro diagnostic devices — covering FDA pathways (OTC, prescription home use, CLIA waiver), EU IVDR self-testing requirements, human factors and lay-user usability, specimen collection errors, labeling requirements, DTC vs provider-ordered models, and post-market surveillance for consumer diagnostics.

Protocol-level analytical validation guide for IVD manufacturers — covering test plan tables, acceptance criteria, sample selection, statistical methods per CLSI standards, and FDA/EU IVDR expectations for analytical performance evidence.

Regulatory and risk assessment guide for medical devices incorporating nanomaterials — covering EU MDR Rule 19 classification, FDA nanotechnology guidance, ISO 10993-22 biocompatibility, SCENIHR exposure framework, nanotoxicology testing, sterilization challenges, labeling requirements, and a decision tree for regulatory strategy.

Comprehensive regulatory and validation strategy for next-generation sequencing (NGS) in vitro diagnostic devices — covering FDA pathways (510(k), De Novo, PMA), proposed CDx reclassification, EU IVDR classification, wet lab and bioinformatics pipeline validation, variant calling, reference databases, clinical validity, cybersecurity, and post-market obligations.

Practical PMCF Plan template aligned with MDCG 2020-7 and EU MDR Annex XIV Part B — covering objectives derivation from CER gaps, method selection (registries, surveys, studies, literature), endpoint definition, sample size logic, schedule, triggers, PMCF evaluation report structure, and PMS integration.

Comprehensive regulatory strategy guide for pre-filled syringes and auto-injectors as drug-device combination products — covering FDA OCP/RFD jurisdiction, ISO 11608 design verification, human factors validation, EU MDR Article 117, QMSR quality system implications, stability testing, and lifecycle change management.

Regulatory strategy guide for surgical robot manufacturers — covering FDA classification (510(k), De Novo, PMA), autonomy levels, software controls (IEC 62304), electrical safety (IEC 60601), usability (IEC 62366), clinical evidence expectations, EU MDR requirements, training programs, and post-market surveillance.

Practical labeling and intended-use boundary guide for IVD manufacturers — covering FDA RUO/IUO guidance, clinical diagnostic use triggers, enforcement actions, marketing language risk, distributor behavior, and a decision tree for regulatory classification.

On March 20, 2026, the European Commission adopted two delegated regulations expanding the Well-Established Technology (WET) list under EU MDR. C(2026) 1798 exempts additional implantable and Class III devices from clinical investigations. C(2026) 1809 simplifies conformity assessment for Class IIb implantable devices. This guide covers what changed, which devices qualify, WET criteria, and practical steps for manufacturers.

Complete guide to benefit-risk analysis for medical devices — ISO 14971:2019 residual risk evaluation, EU MDR AFAP requirements, FDA benefit-risk factors for PMA/De Novo/510(k), MDCG guidance, practical examples, and documentation best practices.

Complete guide to demonstrating clinical equivalence under EU MDR Article 61 and Annex XIV — technical, biological, and clinical characteristics per MDCG 2020-5, differences from MEDDEV 2.7/1 Rev. 4, data access requirements, gap analysis, and practical examples for CE marking.

Complete guide to electronic Instructions for Use (eIFU) for medical devices — EU Implementing Regulation 2021/2226 as amended by Regulation 2025/1234 expanding eIFU to all professional-use devices, risk assessment requirements, labeling obligations, EUDAMED UDI integration, FDA electronic IFU policy under 21 CFR Part 801, paper IFU fallback rules, IVDR provisions for IVDs, SaMD-specific guidance, validation expectations, and implementation checklist.

How much does it cost to register a medical device in the European Union in 2026? A buyer-side breakdown of EU Authorized Representative (EC REP) service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for MDR and IVDR portfolios.

Step-by-step guide to creating a compliant literature search protocol for medical device clinical evaluation under EU MDR Article 61 and Annex XIV — MEDDEV 2.7/1 Rev. 4 methodology, PICO framework, database selection, inclusion/exclusion criteria, critical appraisal, PRISMA documentation, and Notified Body expectations.

Guide to selecting, validating, and using patient-reported outcome (PRO) instruments in medical device clinical trials — FDA CDRH draft guidance on fit-for-purpose PROs, EU MDR clinical evaluation requirements, COA types (PRO, ClinRO, ObsRO, PerfO), instrument validation, endpoint hierarchy, and regulatory submission strategies.

Complete guide to conducting a state of the art (SOTA) review for medical device clinical evaluation under EU MDR — regulatory definitions, SOTA methodology, comparator and benchmark device selection, clinical outcome parameters, MDCG 2020-6 evidence hierarchy, and practical examples for building a defensible CER.